{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.51","value":"0.2"},{"groupId":"OG001","spread":"0.45","value":"0.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"description":"Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC \\<0.5 × 109/L within the first 12 days of chemotherapy.","dispersionType":"Standard Deviation","groups":[{"description":"F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.\n\nF-627: single dose pre-filled syringe","id":"OG000","title":"F-627"},{"description":"6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles\n\nNeulasta: single dose pre-filled syringe","id":"OG001","title":"Neulasta"}],"paramType":"MEAN","populationDescription":"ITT (Intent-to-Treat) population","reportingStatus":"POSTED","timeFrame":"The first of 4, 21-day chemotherapy cycles (average 3 weeks)","title":"Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1","type":"PRIMARY","unitOfMeasure":"days"}